Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2013] FCA 226

Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2013] FCA 226

The manufacture of the tablets was part of the experimental proof of the fact that the respondents sought to establish through later dissolution testing, so r 34.50 was engaged. The respondents had long been on notice of the applicants' objection yet proceeded with manufacture at Lupin Ltd in circumstances that effectively denied the applicants any opportunity to observe it. Because the evidence came only from an observer and not from the formulation scientist or supervisor who carried out the work, it was effectively ipse dixit and not capable of meaningful cross-examination. The prejudice to the applicants made it inappropriate to grant leave under r 34.50(2)(b).

Jurisdiction
Australia
Judgment Date
11 March 2013
Procedural Posture
Interlocutory Application in Federal Court Proceedings Concerning Evidence in Chief on Validity / Application Filed 5 March 2013 for Leave to Rely on the Affidavit of Terence Clive Burgess Sworn 27 September 2012, Heard on the First Day of the Hearing
Outcome
The interlocutory application was dismissed and leave to rely on the affidavit of Terence Clive Burgess sworn 27 September 2012 was refused.
Legal Topics
['experimental Proof of a Fact' 'admissibility of Evidence' 'leave Under Federal Court Rules 2011 R 34.50' 'unfair Prejudice' 'validity Evidence']
['evidence' 'civil Procedure' 'patents'] ['experimental Proof of a Fact' 'admissibility of Evidence' 'leave Under Federal Court Rules 2011 R 34.50' 'unfair Prejudice' 'validity Evidence']

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Procedural Posture

Interlocutory Application in Federal Court Proceedings Concerning Evidence in Chief on Validity / Application Filed 5 March 2013 for Leave to Rely on the Affidavit of Terence Clive Burgess Sworn 27 September 2012, Heard on the First Day of the Hearing

Legal Issues

  1. 1 ['Whether the manufacture of tablets for later dissolution testing constituted part of the experimental proof of a fact under Federal Court Rules 2011 r 34.50' "Whether the respondents should be granted leave under r 34.50(2)(b) to rely on Mr Burgess's affidavit" 'Whether admission of the affidavit would cause unfair prejudice because the applicants were denied an opportunity to observe the manufacture and could not meaningfully cross-examine the evidence']

Ratio Decidendi

The manufacture of the tablets was part of the experimental proof of the fact that the respondents sought to establish through later dissolution testing, so r 34.50 was engaged. The respondents had long been on notice of the applicants' objection yet proceeded with manufacture at Lupin Ltd in circumstances that effectively denied the applicants any opportunity to observe it. Because the evidence came only from an observer and not from the formulation scientist or supervisor who carried out the work, it was effectively ipse dixit and not capable of meaningful cross-examination. The prejudice to the applicants made it inappropriate to grant leave under r 34.50(2)(b).

Court Disposition

The interlocutory application was dismissed and leave to rely on the affidavit of Terence Clive Burgess sworn 27 September 2012 was refused.

Orders

  • ['The interlocutory application filed 5 March 2013 be dismissed.' "The respondents are to pay the applicants' costs of the interlocutory application as agreed or taxed."]